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    Medical device manufacturing and sales industry, manufacturing industry, manufacturing and sales approval and certification

    notification

    Updated: July 2026, 8


    Medical device manufacturing and sales notification

    Issue dateDocument numbernotification name
    26th, April 11Yakushokuki Sanpatsu 1121 No. 41Matters to keep in mind when filing manufacturing and sales notifications for medical devices[PDF]

    Application for controlled medical device manufacturing and sales certification

    Issue dateDocument numbernotification name
    26th, April 11Yakushoku Hatsu 1120 No. 8Regarding application for manufacturing and sales certification of medical devices
    26th, April 11Yakushokuki Sanpatsu 1120 No. 4Matters to keep in mind when preparing an application for manufacturing and sales certification of medical devices
    27th, April 2Yakushokuki Sanpatsu 0210 No. 1Matters to keep in mind when preparing the documents attached to the application form for manufacturing and sales certification of medical devices[PDF]
    27th, April 3Yakushokuki Sanpatsu 0309 No. 1Article 23 of the Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc. Among medical devices that had been approved for manufacture and sale based on the provisions of Article 2-5-1, Paragraph 23 of the Act Regarding the handling of highly controlled medical devices and controlled medical devices that are specified by the Minister of Health, Labor and Welfare based on the provisions of Paragraph 2 of 23-1.[PDF]
    26th, April 9Yakushokuki Sanpatsu 0925 No. 1Certification succession procedures for medical devices and in vitro diagnostic drugs[PDF]
    26th, April 9Yakushokuki Sanpatsu 0925 No. 5About the approval number and how to assign the certification number[PDF]

    Medical device manufacturing and sales approval application

    Issue dateDocument numbernotification name
    26th, April 11Yakushoku Hatsu 1120 No. 5Application for manufacturing and sales approval of medical devices [PDF]
    26th, April 11Yakushokuki Sanpatsu 1120 No. 1Matters to keep in mind when preparing an application for manufacturing and marketing approval for medical devices[PDF]
    27th, April 1Yakushokuki Sanpatsu 0120 No. 9Matters to keep in mind when preparing documents attached to an application for manufacturing and marketing approval of medical devices[PDF]
    27th, April 6Yakushokuki Sanpatsu 0601 No. 1Questions and answers (Q&A) regarding the application form for manufacturing and marketing approval of medical devices and attached documents[PDF]
    26th, April 9Yakushokuki Sanpatsu 0929 No. 1Regarding maintenance of descriptions of approval or certificates for medical devices and in vitro diagnostic drugs [PDF]
    26th, April 11Yakushokuki Sanpatsu 1125 No. 22Regarding questions and answers (Q&A) regarding approval applications for medical devices and in vitro diagnostic drugs, etc.[PDF]
    28th, April 3Yakushoki 0301 No. 1Questions and answers (Q&A) regarding the application form for manufacturing and marketing approval of medical devices and attached documents (Part 2)[PDF]
    26th, April 11Yakushoku Kanpatsu No. 1119 No. 7, Yakushoku Kanpatsu No. 1119 No. 12Expediting procedures for changing or adding manufacturing sites for medical devices and in vitro diagnostic drugs[PDF]
    26th, April 11Yakushokuki Sanpatsu 1121 No. 47Regarding handling of manufacturing and marketing approval (certification) related to multiple brand names of medical devices[PDF]
    26th, April 11Yakushokuki Sanpatsu 1105 No. 5Regarding the handling of standards for medical devices and in vitro diagnostic drugs specified by the Minister of Health, Labor and Welfare pursuant to the provisions of Article 41, Paragraph 3 of the Act on Ensuring the Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc.[PDF]

    Certification standards for highly controlled medical devices/Certification standards for controlled medical devices

    Issue dateDocument numbernotification name
    26th, April 11Yakushoku Hatsu 1105 No. 2Handling of certification standards for highly controlled medical devices[PDF]
    26th, April 11Yakushokuki Sanpatsu 1120 No. 8Regarding the handling of documents related to the reliability of documents to be attached to the application form for certification of highly controlled medical devices[PDF]
    26th, April 11Yakushokuki Sanpatsu 1125 No. 2Procedures for requesting the establishment of certification standards in the certification standards development plan for highly controlled medical devices[PDF]
    27th, April 9Yakushoku Hatsu 0930 No. 2Handling of certification standards for highly controlled medical devices (Part 3)[PDF]
    27th, April 9Yakushoku Hatsu 0930 No. 6Regarding handling of certification standards for controlled medical devices[PDF]
    27th, April 9Yakushokuki Sanpatsu 0930 No. 1Conformity checklist for designated highly controlled medical devices, etc. (Part 3)[PDF]
    27th, April 11Yakuhatsu No. 1118 No. 1Handling of certification standards for highly controlled medical devices (Part 4)[PDF]
    27th, April 11Yakushoki 1124 No. 1Conformity checklist for designated highly controlled medical devices, etc. (Part 4)[PDF]
    27th, April 12Administrative communicationRegarding partial corrections to “Conformity Checklist for Designated Highly Controlled Medical Devices (Part 4)”[PDF]
    27th, April 12Yakuhatsu No. 1224 No. 4Handling of certification standards for highly controlled medical devices (Part 5)[PDF]
    27th, April 12Yakushoki 1224 No. 1Conformity checklist for designated highly controlled medical devices, etc. (Part 5)[PDF]
    28th, April 3Yakuhatsu No. 0330 No. 1Handling of certification standards for highly controlled medical devices (Part 6)[PDF]
    28th, April 3Yakushoki 0330 No. 1Conformity checklist for designated highly controlled medical devices, etc. (Part 6)[PDF]
    28th, April 7Pharmacological Medicines Review No. 0728 No. 1Conformity checklist for designated highly controlled medical devices, etc. (Part 7)[PDF]
    28th, April 11Pharmacological Medicines Review No. 1130 No. 1Conformity checklist for designated highly controlled medical devices, etc. (Part 8)[PDF]

    Notifications related to QMS

    Issue dateDocument numbernotification name
    26th, April 8Yakushoku Hatsu 0812 No. 1Regarding the revision of ministerial ordinances regarding manufacturing control and quality control standards for medical devices and in vitro diagnostic drugs, and the enactment, revision, or abolition of related ministerial ordinances and notifications in accordance with the enforcement of a law that partially amends the Pharmaceutical Affairs Law, etc.[PDF]
    26th, April 8Pharmaceutical Food and Drug Administration Bulletin 0827 No. 4Regarding the revision of the ministerial ordinance regarding manufacturing control and quality control standards for medical devices and in vitro diagnostic drugs in accordance with the enforcement of the law partially amending the Pharmaceutical Affairs Law, etc.[PDF]
    26th, April 9Pharmaceutical Food and Drug Administration Bulletin 0911 No. 1Regarding the ministerial ordinance regarding the standards for the system for conducting operations related to the manufacturing control or quality control of medical devices or in vitro diagnostic drugs[PDF]
    26th, April 9Pharmaceutical Food and Drug Administration Bulletin 0911 No. 5Regarding the applicability of product groups of medical devices and in vitro diagnostic drugs[PDF]
    26th, April 11Pharmaceutical Food and Drug Administration Bulletin 1119 No. 16Applicability of newly added generic names to product groups[PDF]
    26th, April 12Pharmaceutical Food and Drug Administration Bulletin 1202 No. 10Regarding the revision of “Applicability of product groups of medical devices and in vitro diagnostic drugs”[PDF]
    29th, April 3Yakusho Kanma Bulletin 0331 No. 3Regarding partial revisions to “Applicability of product groups of medical devices and in vitro diagnostic drugs”[PDF]
    29th, April 5Yakusho Kanma Bulletin 0526 No. 10Applicability of newly added generic names to product groups[PDF]
    26th, April 10Pharmaceutical Food and Drug Administration Bulletin 1024 No. 10Regarding the establishment of QMS investigation guidelines[PDF]
    26th, April 11Yakushoku Kanpatsu No. 1119 No. 7, Yakushoku Kansai No. 1119 No. 3Information regarding the handling of applications for Certificates of Compliance and QMS Compliance Assessments [PDF]
    26th, April 11Pharmaceutical Food and Drug Administration Bulletin 1121 No. 21Regarding selection of multiple product group classifications in QMS conformity investigation application[PDF]
    26th, April 11Pharmaceutical Food and Drug Administration Bulletin 1121 No. 25Questions and answers (Q&A) regarding manufacturing control and quality control standards for medical devices and in vitro diagnostic drugs[PDF]
    26th, April 12Pharmaceutical Food and Drug Administration Bulletin 1218 No. 4Regarding the establishment of sterilization validation standards[PDF]
    27th, April 3Pharmaceutical Food and Drug Administration Bulletin 0313 No. 8Questions and answers (Q&A) regarding standards for manufacturing control and quality control of medical devices and in vitro diagnostic drugs (Part 2)[PDF]
    27th, April 7Yakushoku Kanpatsu No. 0710 No. 1, Yakushoku Kanpatsu No. 0710 No. 18Regarding application for QMS compatibility investigation when applying for manufacturing and marketing approval for generic medical devices and improved medical devices (limited to cases where clinical trial data are not required) (re-notification)[PDF]

    Notices related to medical device programs

    Issue dateDocument numbernotification name
    26th, April 11Yakushokuki Sanpatsu 1125 No. 6Regarding the handling of manufacturing and sales certification applications for medical device programs
    26th, April 11Pharmaceutical Food and Drug Administration Bulletin 1114 No. 5Basic concept regarding applicability of the program to medical devices
    26th, April 11Yakushokuki Sanpatsu 1121 No. 33
    Pharmaceutical Food Safety Issue 1121 No. XNUMX
    Pharmaceutical Food and Drug Administration Bulletin 1121 No. 29    		Regarding the handling of medical device programs

    Notices related to home electric massagers

    Issue dateDocument numbernotification name
    26th, April 7Yakushokuki 0708 No. 2Regarding the handling of certification examinations for home electric massagers

    Notifications related to contact lenses

    Issue dateDocument numbernotification name
    24th, April 7Yakushoku Hatsu 0718 No. 16Regarding handling of contact lenses when selling them

    Notices related to medical device repair business

    Issue dateDocument numbernotification name
    17th, April 3Pharmaceutical Food and Drug Administration No. 0331008Applicability of medical device repair categories
    17th, April 3Pharmaceutical Food and Drug Administration No. 0331004Regarding the operation, etc. related to the medical device repair business due to the enforcement of the Pharmaceutical Affairs Law and the Act on Partial Amendment of the Blood Collection and Blood Donation Mediation Business Control Law, etc.
    17th, April 4　Regarding Q&A regarding handling of medical equipment repair business, etc.
    25th, April 2　Regarding Q&A regarding handling of medical equipment repair business (Part 2)

    Other Information

    Issue dateDocument numbernotification name
    26th, April 4Pharmaceutical Food and Drug Administration Bulletin 0411 No. 3About split sales of medical devices

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